ISO 9001:2015 - SD Manufacturing 2015... · The new ISO 9001:2015 The new ISO 9001 2015 standard is...
Transcript of ISO 9001:2015 - SD Manufacturing 2015... · The new ISO 9001:2015 The new ISO 9001 2015 standard is...
Key perspectives
ISO 9001 needs to change, to:
adapt to a changing world
reflect the increasingly complex environments in which organizations operate
provide a consistent foundation for the future
ensure the new standard reflects the needs of all relevant interested parties
ensure alignment with other management system standards
Key benefits of thecommon clause structure
A new common format has been developed
All ISO management systems standards will look
the same with the same structure (some deviations)
More efficient to address multiple management
system requirements
Provides the option of integrating management
systems
Standardized core definitions
Beneficial changes to ISO 9001
Enhanced leadership involvement in the management system
Risk-based thinking
Simplified language, common structure and terms
Aligning QMS policy and objectives with the strategy of the organization
Potential benefitsto the user
Focus on achieving planned results
Flexibility for documented information
Improved risk control
Better process control leading to improved results
Improved customer satisfaction
Customer retention and loyalty
Improved image and reputation
Greater credibility
Use ISO 9001:2015 if:
You need to be able to show that your organization is consistently capable of providing products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements.
You need to be able to demonstrate that your organization can enhance customer satisfaction because it is consistently capable of continually improving both its products and services and its practices and processes.
You need to be able to assess your organization's ability to consistently provide products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements.
The new ISO 9001:2015
The new ISO 9001 2015 standard is based on seven quality management principles. These principles were chosen because they can be used to enhance corporate performance and to achieve sustained success. They form the conceptual foundation for the ISO portfolio of quality management standards and were used to guide the development of this new standard.
Focus on customers and interested parties
In order to enhance corporate performance and achieve sustained success, organizations must focus on both their customers and their interested parties. Organizations can establish this focus by trying to understand the current and future requirements and expectations of both their customers and their interested parties and by constantly trying to meet these requirements and exceed these expectations.
Provide leadership for your organization
In order to enhance corporate performance and achieve sustained success, organizations must ensure that suitable leadership is provided at all levels. Suitable leadership is provided whenever leaders at all levels establish a unity of purpose and whenever they create an environment that encourages people to pursue a common directionand achieve a common set of objectives. By establishing a common purpose, leaders can ensure that all strategies, policies, processes, and resources are aligned and being used to pursue a common direction and to achieve a common set of objectives.
Engage and involve your people
In order to enhance corporate performance and achieve sustained success, organizations must be able to create and deliver value. In order to do so they must have people who are competent, they must enhance their knowledge and skills, and they must manage them effectively by empowering them, by encouraging their involvement and engagement at all levels, and by recognizing their achievements.
Use a process approach
In order to enhance corporate performance and achieve sustained success, organizations must use a process approach to manage their activities. The process approach is a management strategy. When managers use this approach, it means that they manage and control their processes, the interactions between these processes, and the inputs and outputs that tie these processes together. It also means that they manage these interactions as a system. When this approach is applied to quality management, it means that they manage their processes and their process interactions as a coherent quality management system.
Encourage improvement
In order to enhance corporate performance and achieve sustained success, organizations must encourage and support improvement. If they wish to maintain current levels of performance, if they wish to respond to changing conditions, and if they wish to identify, create, and exploit new opportunities, organizations must establish and sustain an ongoing focus on improvement.
Use evidence to make decisions
In order to enhance corporate performance and achieve sustained success, organizations must establish an evidence-based decision making process. Decision making is evidence-based whenever multiple types of input are gathered from multiple sources, whenever facts are identified, whenever data is analyzed objectively, whenever cause and effect relationships are examined, whenever potential unintended consequences are considered, and whenever all of this is used to make corporate decisions.
Manage your corporate relationships
In order to enhance corporate performance and achieve sustained success, organizations must manage their relationship with suppliers, partners, and other interested parties. Relationships must be carefully managed because suppliers, partners, and other interested parties can influence corporate performance and undermine corporate success.
Structure of the standard
Perhaps the biggest difference between the old and the new standard is the structure. ISO 9001 2008 had five main sections (4 to 8) and ISO 9001 2015 now has seven (4 to 10). This is because the new edition uses the new Annex SL template. According to ISO, all future management system standards (MSSs) will use this new layout and share the same basic requirements.
ISO 9001:2015 to ISO 9001:2008Correlation Matrix
ISO 9001:2015 ISO 9001:2008
1 Scope 1 Scope
1.1 General
4 Context of the organization 4 Quality management system
4.1 Understanding the organization and its context
4 Quality management system
5.6 Management review
4.2 Understanding the needs and expectations of interested parties
4 Quality management system
5.6 Management review
4.3 Determining the scope of the quality management system
1.2 Application
4.2.2 Quality manual
4.4 Quality management system and its processes
4 Quality management system
4.1 General requirements
5 Leadership 5 Management responsibility
5.1 Leadership and commitment 5.1 Management commitment
5.1.1 General 5.1 Management commitment
5.1.2 Customer focus 5.2 Customer focus
5.2 Policy 5.3 Quality policy
5.2.1 Establishing the Quality Policy 5.3 Quality policy
5.2.2 Communicating the Quality Policy 5.3 Quality policy
5.3 Organizational roles, responsibilities and authorities
5.5.1 Responsibility and authority
5.5.2 Management representative
5.4.2 Quality management system planning
6 Planning 5.4.2 Quality management system planning
6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning
8.5.3 Preventive action
6.2 Quality objectives and planning to achieve them
5.4.1 Quality objectives
6.3 Planning of changes 5.4.2 Quality management system planning
ISO 9001:2015 to ISO 9001:2008Correlation Matrix
7 Support 6 Resource management
7.1 Resources 6 Resource management
7.1.1 General 6.1 Provision of resources
7.1.2 People 6.1 Provision of resources
7.1.3 Infrastructure 6.3 Infrastructure
7.1.4 Environment for the operation of processes
6.4 Work environment
7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring equipment
7.1.5.1 General 7.6 Control of monitoring and measuring equipment
7.1.5.2 Measurement traceability 7.6 Control of monitoring and measuring equipment
7.1.6 Organizational knowledge No equivalent clause
7.2 Competence 6.2.1 General
6.2.2 Competence, training and awareness
ISO 9001:2015 to ISO 9001:2008Correlation Matrix
7.3 Awareness 6.2.2 Competence, training and awareness
7.4 Communication 5.5.3 Internal communication
7.5 Documented information 4.2 Documentation requirements
7.5.1 General 4.2.1 General
7.5.2 Creating and updating 4.2.3 Control of documents
4.2.4 Control of records
7.5.3 Control of documented Information 4.2.3 Control of documents
4.2.4 Control of records
ISO 9001:2015 to ISO 9001:2008Correlation Matrix
8 Operation 7 Product realization
8.1 Operational planning and control 7.1 Planning of product realization
8.2 Requirements for products and services
7.2 Customer-related processes
8.2.1 Customer communication 7.2.3 Customer communication
8.2.2 Determination of requirements for products and services
7.2.1 Determination of requirements related to the product
8.2.3 Review of the requirements for products and services
7.2.2 Review of requirements related to the product
8.2.4 Changes to requirements for products and services
7.2.2 Review of requirements related to the product
8.3 Design and development of products and services
7.3Design and development
8.3.1 General 7.3.1 Design and development planning
8.3.2 Design and development planning 7.3.1 Design and development planning
8.3.3 Design and development inputs 7.3.2 Design and development inputs
8.3.4 Design and development controls 7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
8.3.5 Design and development outputs 7.3.3 Design and development outputs
8.3.6 Design and development changes 7.3.7 Control of design and development changes
ISO 9001:2015 to ISO 9001:2008Correlation Matrix
8.4 Control of externally provided processes, products and services
7.4.1 Purchasing process
8.4.1 General 4.1 General requirements
7.4.1 Purchasing process
8.4.2 Type and extent of control 7.4.1 Purchasing process
7.4.3 Verification of purchased product
8.4.3 Information for external providers 7.4.2 Purchasing information
7.4.3 Verification of purchased product
8.5 Production and service provision 7.5 Production and service provision
8.5.1 Control of production and service provision
7.5.1 Control of production and service
provision
7.5.2 Validation of processes for production and service provision
8.5.2 Identification and traceability 7.5.3 Identification and traceability
8.5.3 Property belonging to customers or external providers
7.5.4 Customer property
8.5.4 Preservation 7.5.5 Preservation of product
8.5.5 Post-delivery activities 7.5.1 Control of production and service provision
8.5.6 Control of changes 7.3.7 Control of Design and Development Changes
8.6 Release of products and services 7.4.3 Verification of purchased product
8.2.4 Monitoring and measurement of product
8.7 Control of nonconforming outputs 8.3 Control of nonconforming product
ISO 9001:2015 to ISO 9001:2008Correlation Matrix
9 Performance evaluation 8 Measurement, analysis and improvement
9.1 Monitoring, measurement, analysis and evaluation
8 Measurement, analysis and improvement
9.1.1 General 8.1 General
8.2.3 Monitoring and Measurement Processes
9.1.2 Customer satisfaction 8.2.1 Customer satisfaction
9.1.3 Analysis and evaluation 8.4 Analysis of data
9.2 Internal audit 8.2.2 Internal audit
9.3 Management review 5.6 Management review
9.3.1 General 5.6.1 General
9.3.2 Management review input 5.6.2 Review input
9.3.3 Management review output 5.6.3 Review output
10 Improvement 8.5 Improvement
10.1 General 8.5.1 Continual improvement
10.2 Nonconformity and corrective action 8.3 Control of nonconforming product
8.5.2 Corrective action
10.3 Continual Improvement 8.5.1 Continual improvement
8.5.3 Preventive action
Key feature changes
10-clause structure and core text for all Management System
Standards (MSS)
More compatible with services and non-manufacturing users
Clearer understanding of the organization’s context is required
“one size doesn’t fit all”
Process approach strengthened/more explicit
Concept of preventive action now addressed throughout the
standard by risk identification and mitigation
The term documented information replaces the terms document
and record
Control of externally provided products and services replaces
purchasing/outsourcing
Increased emphasis on seeking opportunities for improvement
Context of the organization
Unlike the old standard, the new one expects you to understand your organization's context before you establish its QMS. This means that you need to understand your organization's external environment, its culture, its values, its performance, and its interested parties before you develop its QMS. Why? Because your QMS will need to be able to manage all of these influences.
Use a process approach
In order to enhance corporate performance and achieve sustained success, organizations must use a process approach to manage their activities. When thisapproach is applied to quality management, it means that they manage their processes and their process interactions as a coherent quality management system.
Risk-based thinking
ISO 9001 has always been about anticipating and preventing mistakes, which is what risk-based thinking is all about. That's why we train people, why we plan our work, why we assign roles and responsibilities, why we validate and verify results, why we audit and review activities, and why we monitor, measure, and control processes. We do these things because we want to prevent mistakes. We do them because we're trying to manage risk. So, if we think of risk-based thinking in this way, it's always been an inherent part of ISO 9001. Before it was implicit; now it's explicit.
Documented information
According to ISO's definition, the term documented information refers to information that must be controlled and maintained. So, whenever ISO 9001 2015 uses the term documented information it implicitly expects you to control and maintain that information and its supporting medium. An annex to the new standard (A.6) further says that "Where ISO 9001:2008 would have referred to documented procedures ... this is now expressed as a requirement to maintain documented information”, and "Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information".
Documented information
So, whenever the new standard refers to documented information and it asks you to maintain this information, it's talking about what used to be referred to as procedures, and whenever it asks you to retain this information, it's talking about what used to be called records. So sometimes it must be maintained and sometimes it must be retained.
Encourage improvement
In order to enhance corporate performance and achieve sustained success, organizations must encourage and support improvement. If they wish to maintain current levels of performance, if they wish to respond to changing conditions, and if they wish to identify, create, and exploit new opportunities, organizations must establish and sustain an ongoing focus on improvement.
Requirements and exclusions
Section 4.3 of ISO 9001 2015 says “The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system”. However, while the new ISO 9001 2015 standard says that every requirement must be applied, section 4.3 and Annex A5 also says that any requirement may be excluded if it cannot be applied, if you can justify and explain why it can’t be applied, and if excluding it does not undermine your ability or responsibility to ensure that products and services are in compliance.
Structure of ISO 9001:2015
1 Scope 2 Normative references 3 Terms and definitions
4 Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested
parties4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes
5 Leadership5.1 Leadership and commitment5.2 Policy 5.3 Organizational roles, responsibilities and authorities
6 Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes
Structure of ISO 9001:2015 7 Support
7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
8 Operation 8.1 Operational planning and control8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and
services8.5 Production and service provision8.6 Release of products and services8.7 Control of nonconforming outputs
Structure of ISO 9001:20159 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
The common structure and ISO 9001:2015 additions
4 Context of organization
5 Leadership 6 Planning 7 Support 8 Operation9 Performance Evaluation
10 Improvement
4.1 Understanding context
4.2 Interested parties
4.3 Scope
4.4 QMS
5.1 Leadership and commitment
6.1 Risks and opportunities
6.2 Planning
7.1 Resources
9.1 Monitoring, measurement, analysis and evaluation
10.1 General
10.3 Continual improvement
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence 9.2
Internal audit
9.3 Management review
8.1 Operational planning and control
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
10.2 Nonconformity and corrective action
Do Check ActPlan
4 Context of
organization
5 Leadership
6 Planning
8 Operation
9 Performance
and Evaluation
10 Improvement
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
5.1 Leadership and
commitment
6.1 Actions to
address risks and opportunities
6.2 Quality objectives
and planning
9.1 Monitoring,
measurement, analysis and evaluation
10.2 Nonconformity and corrective
action
10.3Continual
improvement
5.3Organizational
roles, responsibilities and authorities
9.2Internal audit
9.3 Management
review
8.1 Operational
planning and control
5.2 Policy
6.3 Planning of
changes
9.1.2Customer
satisfaction
9.1.3 Analysis and
evaluation
See next slide
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
10.1General
Clause 4.1 Determine what the relevant external and internal issues are for your organization, and that are relevant to its strategic direction
4 Context of
organization
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
Clause 4.2Identify the relevant interested parties and their relevant requirements
4 Context of
organization
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
Clause 4.3 and 4.4
The requirement for the scope is now better defined, must be documented and consider:
external and internal issues
requirements of relevant interested parties
the products and services covered (must also be stated in scope)
allowing applicability of specific requirements
justification for any case where a requirement cannot be applied (exclusion)
4 Context of
organization
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
4 Context of
organization
5 Leadership
6 Planning
8 Operation
9 Performance
and Evaluation
10 Improvement
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
5.1 Leadership and
commitment
6.1 Actions to
address risks and opportunities
6.2 Objectives and
planning
9.1 Monitoring,
measurement, analysis and evaluation
5.3 Organizational
roles, responsibilities and authorities
9.2Internal audit
9.3 Management
review
8.1 Operational
planning and control
5.2 Policy
6.3 Planning of
changes
9.1.2Customer
satisfaction
9.1.3 Analysis and
evaluation
See next slide
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
10.2 Nonconformity and corrective
action
10.3Continual
improvement
10.1General
Clause 5.1.1
Leadership is required to ensure:
take accountability for the effectiveness of the quality management system
ensure the quality policy and quality objectives are compatible with the context and strategic direction of the organization
ensure the integration of the QMS requirements into the organization’s business processes
promote the use of the process approach and risk-based thinking
ensure that the QMS achieves its intended results
engage, direct and support persons to contribute to the effectiveness of the QMS
supporting relevant management roles
promotion of improvement
Clause 5.1.2
Top management needs to ensure customer satisfaction through:
customer and applicable statutory and regulatory requirements being determined and met
risk and opportunities are being addressed
the focus on products and services meeting customers and other requirements
5 Leadership
5.1 Leadership and
commitment
5.2Policy
5.3Organizational roles, responsibilities and
authorities
5 Leadership
5.1 Leadership and
commitment
5.3Organizational roles, responsibilities and
authorities
5.2 Policy
Clause 5.2
Explicit requirement to apply the policy
Clause 5.2
Explicit requirement to apply the policy
Clause 5.3
Explicit requirement for relevant roles to be assigned,
communicated and understood
No requirement for a specific management
representative and the responsibility now resides with
top management to assign and manage
Requirement for defining responsibility and authority
for ensuring processes are delivering their intended
outputs
5 Leadership
5.1 Leadership and
commitment
5.2Policy
5.3Organizational roles, responsibilities and
authorities
4 Context of
organization
5 Leadership
6 Planning
8 Operation
9 Performance
and Evaluation
10 Improvement
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
5.1 Leadership and
commitment
6.1 Actions to
address risks and opportunities
6.2 Quality objectives
and planning
9.1 Monitoring,
measurement, analysis and evaluation
5.3Organizational
roles, responsibilities and authorities
9.2Internal audit
9.3 Management
review
8.1 Operational
planning and control
5.2 Policy
6.3 Planning of
changes
9.1.2Customer
satisfaction
9.1.3 Analysis and
evaluation
See next slide
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
10.2 Nonconformity and corrective
action
10.3Continual
improvement
10.1General
Clause 6.1
Considering the issues raised and relevant interested
parties’ requirements identified (4.1 and 4.2), this clause
requires the determination of risks and opportunities
which need to be addressed, actions to be taken and
evaluation of the effectiveness of these actions
6 Planning
6.1 Actions to address risks
and opportunities
6.2 Objectives and planning
6.3 Planning of changes
Clause 6.2
Objectives should be:
established for processes relevant to the QMS
in line with customer requirements
in line with products and services conformity
monitored, communicated & updated
6 Planning
6.1 Actions to address risks
and opportunities
6.2 Objectives and planning
6.3 Planning of changes
Clause 6.3
Changes to the QMS should be carried out in a planned manner
The standard has evolved to enable organizations to adapt to changing environments or circumstances
Note: It is important to know that change is addressed in the following clauses:
Clause 6.3 - Planning/implementing changes to the QMS
Clause 7.1.6 - Organizational knowledge - for addressing changing needs and trends, with respect to knowledge
Clause 8.1 - Controlling operational changes, planned and unintentional
Clause 8.5.6 - Addressing changes affecting products & services
6 Planning
6.1 Actions to address risk
and opportunity
6.2 Objectives and planning
6.3 Planning of changes
4 Context of
organization
5 Leadership
6 Planning
8 Operation
9 Performance
and Evaluation
10 Improvement
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
5.1 Leadership and
commitment
6.1 Actions to
address risks and opportunities
6.2 Objectives and
planning
9.1 Monitoring,
measurement, analysis and evaluation
5.3 Organizational
roles, responsibilities and authorities
9.2Internal audit
9.3 Management
review
8.1 Operational
planning and control
5.2 Policy
6.3 Planning of
changes
9.1.2Customer
satisfaction
9.1.3 Analysis and
evaluation
See next slide
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
10.2 Nonconformity and corrective
action
10.3Continual
improvement
10.1General
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
Clause 7.1
There should be adequate resources to ensure effectiveness of the QMS. Resource considerations now include:
internal resources
external providers
people
monitoring and measuring resources
organizational knowledge required to ensure the processes provide conforming products and services
external communication
.
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
Clause 7.3 and 7.4
Relevant persons doing work under the organization’s control need to have awareness and communication (internal and external) of the QMS and benefits of improving performance
7 Support
Clause 7.5.1
Requirements that used to be required for a quality manual have been enhanced and made more flexible to allow for the use of documented information needed for the quality management system
Clause 7.5.2
Enhanced requirement for the creation and updating of documented information, e.g. description, format & suitability
Clause 7.5.3
Control of documented information – now explicitly includes confidentiality, integrity and access
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
4 Context of
organization
5 Leadership
6 Planning
8 Operation
9 Performance
and Evaluation
10 Improvement
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
5.1 Leadership and
commitment
6.1 Actions to
address risks and opportunities
6.2 Objectives and
planning
9.1 Monitoring,
measurement, analysis and evaluation
5.3Organizational
roles, responsibilities and authorities
9.2Internal audit
9.3 Management
review
8.1 Operational
planning and control
5.2 Policy
6.3 Planning of
changes
9.1.2Customer
satisfaction
9.1.3 Analysis and
evaluation
See next slide
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
10.2 Nonconformity and corrective
action
10.3Continual
improvement
10.1General
8.1 Operational planning and control
8.3.6 Design and development changes
8.5.3 Property belonging to customers or external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.6 Control of changes
8.7 Control of nonconforming process outputs
8.5.4 Preservation
8.5.5 Post-delivery activities
8.6 Release of products and services
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determination of requirements related to products and services
8.2.3 Review of requirements related to products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development Inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
4 Context of
organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance and
Evaluation
10 Improvement
8.2.4 Changes to requirements for products and services
Clause 8.1.b
explicit requirement for establishing criteria for processes
Clause 8.2.1
explicit considerations are now linked to: customer communications; customer property, and contingency actions
Clause 8.2.2
Determination of requirements; this requires a process and is explicit with regard to substantiating claims for products and services being offered
8.1 Operational planning and control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determination of requirements related to products and services
8.2.3 Review of requirements related to products and services
8 Operation
8.2.4 Changes to requirements for products and services
Clause 8.3
This section on design and development of products and services has substantively changed and simplified:
Clause 8.3.2
Design and development has been restructured to allow for a more process orientated approach
Involvement of customers and users as part of design planning to be considered
Clause 8.3.3
Design and development inputs – explicit requirements for internal and external resource needs, potential consequences of failure, level of control expected by customers
Clause 8.3.4
Design and development controls – new clause combining Reviews, Verification & Validation
8 Operation
8.3.6 Design and development changes
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
Clause 8.4
The terms which previously referred to purchasing and ‘outsourcing’ is now ‘Control of externally provided processes, products and services’
Clause 8.4.1
Conditions are applied when controls are required for externally provided processes, products and service
Terminology has changed from ‘supplier’ to ‘external provider’
Clause 8.4.2
Type and extent of control of external provision previous notes in 4.1 (ISO 9001:2008) now turned into requirements
Clause 8.4.3
Information for external providers are now more detailed and explicit
8.4 Control of externally provided processes products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8 Operation
Clause 8.5.1
This clause specifically considers:
monitoring and measurement activities will ensure the control of processes and output (clauses 8.2.3 and 8.2.4 of ISO 9001:2008 have been moved to 8.5.1)
acceptance criteria for products and services are met
the use, and control of suitable infrastructure and process environment
suitable monitoring and measuring resources
Requires competent persons
8.5.3 Property belonging to customers or external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.6 Control of changes
8.5.4 Preservation
8.5.5 Post-delivery activities
8 Operation
Clause 8.5.2
The identification and traceability now focus on ‘outputs’ rather than on ‘product’ (includes intermediate products and services) rather than on ‘product’
Clause 8.5.3
Customer property has been expanded to include external providers’ property
Clause 8.5.4
Preservation of product has been changed to preservation of the output
Clause 8.5.5
Post-delivery activities is a new clause
Clause 8.5.6
A new requirement for the control of changes is addressed in the slide introducing the concept of change
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.6 Control of changes
8.5.5 Post-delivery activities
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8 Operation
Clause 8.6
The release of products and services is now part of the operational requirements
Clause 8.7
The control of nonconforming output is more explicit; it now considers the options to apply correction and corrective action
Nonconforming product changed to nonconforming output
8.6 Release of products and services
8.7 Control of nonconforming outputs
8 Operation
4 Context of
organization
5 Leadership
6 Planning
8 Operation
9 Performance
evaluation
10 Improvement
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
5.1 Leadership and
commitment
6.1 Actions to
address risks and opportunities
6.2 Quality objectives
and planning
9.1 Monitoring,
measurement, analysis and evaluation
5.3Organizational
roles, responsibilities and authorities
9.2Internal audit
9.3 Management
review
8.1 Operational
planning and control
5.2 Policy
6.3 Planning of
changes
9.1.2Customer
satisfaction
9.1.3 Analysis and
evaluation
See next slide
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
10.2 Nonconformity and corrective
action
10.3Continual
improvement
10.1General
Clause 9.1.1
In 8.1 ISO 9001:2008 (clause 8.1) there was a requirement for planning. This is replaced with identifying what needs monitoring and measuring, and the methods to be used
Clause 9.1.3
There are specific requirements for analysis and evaluation when using results as inputs to management review
Effective implementation of planning and actions to address risks and opportunities are new requirements in this clause
9 Performance
evaluation
9.2Internal audit
9.3 Management review
9.1.2Customer satisfaction
9.1.3 Analysis and evaluation
9.1.1 General
9.1 Monitoring,
measurement, analysis and evaluation
Clause 9.2 Internal audit program now has explicit considerations for:
quality objectives, customer feedback and changes impacting the organization; management responsibility for action is now implicit whereas previously this was explicit
An auditor is now required to be impartial versus in the previous version they could not audit their own work
Clause 9.3 There are now additional requirements for management
review. These include:
changes in external and internal issues (such as strategic direction)
performance concerning external providers
adequacy of resources for effective QMS and effectiveness of actions taken addressing risks & opportunities
Clause 9.3.1 Management reviews should be aligned to the strategic
direction of the organization
Clause 9.3.3 Management review outputs have been enhanced to include
many of the new areas of focus
9 Performance Evaluation
9.1 Monitoring,
measurement, analysis and evaluation
9.2Internal audit
9.3 Management review
9.1.2Customer satisfaction
9.1.3 Analysis and evaluation
9.3.1 General
9.3.3 Management review
output
9.3 .2Management review
input
4 Context of
organization
5 Leadership
6 Planning
8 Operation
9 Performance Evaluation
10 Improvement
4.1 Understanding
context
4.2 Interested parties
4.3 Scope
4.4QMS
5.1 Leadership and
commitment
6.1 Actions to
address risks and opportunities
6.2 Objectives and
planning
9.1 Monitoring,
measurement, analysis and evaluation
10.1 General
10.2 Nonconformity and corrective
action5.3
Organizational roles,
responsibilities and authorities
9.2Internal audit
9.3 Management
review
8.1 Operational
planning and control
5.2 Policy
6.3 Planning of
changes
9.1.2Customer
satisfaction
9.1.3 Analysis and
evaluation
See next slide
7 Support
7.1 Resources
7.3 Awareness
7.4 Communication
7.5 Documented information
7.2 Competence
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.2 People
7.1.3 Infrastructure
7.1.6 Organizational
knowledge
10.3Continual
improvement
Clause 10.1 This clause is new, it addresses more comprehensive
opportunities for improvement; not only continual improvement Addresses improvement of products and services and future
needs and expectations Emphasis is now on improving processes to prevent
nonconformities and improving products and servicesClause 10.2 The nonconformity referred to in this clause concerns the entire
QMS and not specifically the products or services which are addressed under clause 8.7
Clause 10.2.1 New emphasis is placed on nonconformity and corrective action Consequences are now included thus actions taken now
recognize the potential occurrence of a similar nonconformity elsewhere
Risks and opportunities now need to be updated when required following a nonconformity
Clause 10.2.2 Documented information is now required on the nature of the
nonconformity and subsequent actions takenClause 10.3 Opportunities shall be addressed as part of continual
improvement
10 Improvement
10.2 Nonconformity and corrective action
10.3 Continual improvement
10.1 General
Summary Determining the organizational context enables a more effective
implementation of the quality management system
Greater emphasis on processes being managed to achieve
planned results
Alignment with strategic direction
Integration of the QMS into organization’s business processes
Determining risks and opportunities increase the effectiveness
of the organization’s QMS
Change management has been expanded to add emphasis that
the QMS should be carried out in a planned manner
The concept of organizational knowledge introduced to ensure
the organization acquires and maintains the necessary
knowledge
Communication expanded to include external
ISO 9001:2015 CertificationTransition Timeline
September 2015 start of 3 years transition period to September 2018Certifications to ISO 9001:2008 will no longer be valid after September 2018
2018201720162015
September 2015
Published International Standard
Brad Fischer
SD Manufacturing & Technology Solutions
605-202-9118
www.sdmanufacturing.com
Contact Information